Clinical Trial: Study of the Effect of Armodafinil Treatment in Healthy Subjects With Excessive Sleepiness Associated With Jet Lag Disorder

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A 3-Day, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Effect of Armodafinil Treatment (50 and 150 mg/Day) in Healthy Subjects With Excessive Sleepiness Associated With

Brief Summary: This is a randomized, double-blind, placebo-controlled, parallel-group study of armodafinil and placebo treatment in healthy subjects with excessive sleepiness associated with jet lag disorder.

Detailed Summary:
Sponsor: Cephalon

Current Primary Outcome:

• Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Test (MSLT)- Average of Four Scheduled Naps Across Days 1 and 2 [ Time Frame: Days 1 and 2 ]
  MSLT is an assessment that measures likelihood of falling asleep. Mean Sleep Latency measures the time to fall asleep. On Treatment Days 1 and 2 the subject was instructed on 4 occasions to attempt to fall asleep. Each MSLT nap continued until 3 consecutive 30-second epochs of stage 1 sleep were reached, or any 30 second epoch of stage 2, 3, 4 or rapid eye movement sleep was reached. Each nap was terminated after 20 minutes if no sleep occured. Average sleep latency for the 4 naps was tabulated across days 1 and 2. Sleep latency was measured from lights out to first epoch scored as sleep.
• Average of Patient Global Impression of Severity (PGI-S) of General Condition Ratings Across Days 1 and 2 [ Time Frame: Days 1 and 2 ]
  The PGI-S rating scale is the patient's assessment of their general condition. The subject rates their overall condition according to the 7 following categories: 1=normal (no sign of illness), 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, and 7=among the most extremely ill. The term "ill" refers here to any symptoms of jet lag and overall feeling. Symptoms may include sleepiness, irritability, malaise, gastrointestinal disturbance, and level of performance. The average of PGI-S ratings across days 1 and 2 are presented here.

Original Primary Outcome:

• Multiple Sleep Latency Test (MSLT) [ Time Frame: Days 1 and 2 ]
• Patient Global Impression of Severity (PGI-S) ratings [ Time Frame: Days 1 and 2 ]

Current Secondary Outcome:

• Average of Scores Across Days 1 and 2 in the Karolinska Sleepiness Scale (KSS) [ Time Frame: Days 1 and 2 ]

  The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep).

  The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS least squares mean score across days 1 and 2 are reported here.

• Mean Scores From the Karolinska Sleepiness Scale (KSS) at Day 1 [ Time Frame: Day 1 ]

  The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep).

  The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS least squares mean score across day 1 is reported here.

• Mean Scores From the Karolinska Sleepiness Scale (KSS) at Day 2 [ Time Frame: Day 2 ]

  The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep).

  The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS Least squares mean score as measured on day 2 is reported here.

• Mean Scores From the Karolinska Sleepiness Scale (KSS) at Day 3 [ Time Frame: Day 3 ]

  The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep).

  The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS least squares mean score as measured on day 3 is reported here.

• Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Baseline [ Time Frame: Baseline prior to starting study medication ]

  The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep).

  The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS mean score as measured at Baseline, collected at bedtime, is reported here.

• Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Day 1 [ Time Frame: Day 1 bedtime ]

  The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep).

  The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS mean score as measured on day 1, collected only at bedtime, is reported here.

• Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Day 2 [ Time Frame: Day 2 bedtime ]

  The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep).

  The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS mean score as measured on day 2, collected only at bedtime, is reported here.

• Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Day 3 [ Time Frame: Day 3 bedtime ]

  The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep).

  The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS mean score as measured on day 3, collected only at bedtime, is reported here.

• Mean Ratings From the Mean Sleep Latency of the Multiple Sleep Latency Tests (MSLT) at Baseline [ Time Frame: Baseline defined as Screening Visit 2 within 8 weeks prior to Treatment Day 1 ]
• Karolinska Sleepiness Scale (KSS) [ Time Frame: Days 1, 2, and 3 ]
• Nocturnal Polysomnography (NPSG) assessment [ Time Frame: Day 2 ]

Dates:
Date Received: September 23, 2008
Date Started: September 2008
Date Completion:
Last Updated: July 12, 2013
Last Verified: July 2013